Prescription drug · ANDA
Dapsone (daspone) NDC 69238-1627
Dapsone 75 mg/g · Gel · Topical · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1627-6 | 69238162706 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-6) / 60 g in 1 BOTTLE, PUMPMarketed from Jun 2, 2023 | |
| 69238-1627-9 | 69238162709 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-9) / 90 g in 1 BOTTLE, PUMPMarketed from Jun 2, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dapsone
- Generic name (nonproprietary)
- daspone
- Active ingredients
- Dapsone — 75 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212701
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 69238-1627_0622cdcc-1196-4a2f-8c85-6f34f0f97f9dSPL ID 0622cdcc-1196-4a2f-8c85-6f34f0f97f9dSPL set ID fba0b181-077a-4667-bde1-cf9592f120c2RxCUI 1741905UNII 8W5C518302
- Pharmacologic class
- Sulfone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238162706followed by a unit qualifier and the quantityPackage 69238-1627-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1) .
Excerpt only. Read the full label for complete information.